INTERLOCKING DETACHABLE COIL SYSTEM (IDC)— 510(k) K040342

Substantially Equivalent

Boston Scientific Corp

FDA 510(k) clearance K040342 for INTERLOCKING DETACHABLE COIL SYSTEM (IDC), Substantially Equivalent on 2004-04-13. Applicant: Boston Scientific Corp.

Clearance details

Applicant: Boston Scientific Corp
Product code: Code KRD
Advisory panel: Cardiovascular
Date received: 2004-02-12
Decision date: 2004-04-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Natick,, MA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code KRD

product code KRD

Death: 119
Injury: 1,869
Malfunction: 7,015
Other: 1
Total: 9,004

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.